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Abstract

Traditional medicines (TMs) play an important role in maintaining public health, especially for those living in remote and rural areas. It is reported that 80% of the Indian population living in the rural sector depend primarily on the TMs. A well-structured regulatory control mechanism yet to be implemented in most of the developing countries. In India, the authority has given special attention to the safe use of TMs and to sustain its quality as well as safety among users. The Drugs and Cosmetics Act 1940 and Rules, 1945, is the law that regulates the TMs in India and is being amended many times. The act speaks the provisions related to the regulation pertaining to the manufacture and other activities such as manufacturing, packaging, labeling, standards, and sale of TMs. To manufacture good quality indigenous medicines in India, good manufacturing practices have been made mandatory by incorporation of revised Schedule T in the act. The present review highlights the current regulatory situation of TMs in India and the various approaches adopted in Indian regulation to ensure its quality and safety among the users.

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	JPR Solutions

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